Preclude Dura Substitute

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K953969 ↗

FDA product code

GXQ

Device class

Class II

Regulation

21 CFR Part 882.5910

Advisory committee

Neurology

FDA decision

SESE Substantially Equivalent

• GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

  Class III

  CE/MDR MDR 732278 Expiring Valid to Feb 2027

• GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface

  Class III

  CE/MDR MDR 731181 Active Valid to Jul 2031

• GORE-TEX® Stretch Vascular Graft

  Class III

  CE/MDR MDR 732281 Active Valid to Jul 2031

• GORE® EXCLUDER® Iliac Branch Endoprosthesis

  Class III

  CE/MDR MDR 731176 Active Valid to Jul 2031

• GORE® DrySeal Flex Introducer Sheath

  Class III

  CE/MDR MDR 764343 Active Valid to Apr 2028

• GORE® EXCLUDER® Conformable AAA Endoprosthesis

  Class III

  CE/MDR MDR 731175 Active Valid to Jul 2031

See all devices from W. L. Gore & Associates, Inc. →

• What is the Preclude Dura Substitute used for in neurosurgical procedures?

  The Preclude Dura Substitute is designed to replace the protective dura mater layer surrounding the spinal cord during neurosurgical procedures. It acts as a synthetic barrier to support tissue integration and reduce risks like cerebrospinal fluid leakage or postoperative infections.

• Is the Preclude Dura Substitute intended for reuse, or is it meant for single-use only?

  The Preclude Dura Substitute is explicitly supplied as a sterile, single-use implant. This ensures patient safety and compliance with sterile surgical environments, as reuse is not recommended or supported by the manufacturer.

• How is the Preclude Dura Substitute supplied, and what sizes are available?

  The device comes in various sizes, each referenced by the product code GXQ. While exact dimensions are not detailed here, the product codes correspond to different configurations tailored for neurosurgical applications. It is supplied sterile and ready for immediate use in surgical settings.

• What regulatory pathway was followed for FDA clearance of the Preclude Dura Substitute?

  The Preclude Dura Substitute received FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent (SESE) to predicate devices. It is classified under FDA regulation 882.5910 as a Class II medical device and falls under the Neurology specialty category.

• How should the Preclude Dura Substitute be stored before use?

  While specific storage instructions are not detailed here, the device is supplied sterile and intended for use in sterile surgical environments. Proper storage should follow standard medical device protocols to maintain sterility until implantation, such as keeping it in a sealed, dry, and protected environment away from direct sunlight or extreme temperatures.